How to report ADRs through various ways and its importance public health sector.

1. SPONTANEOUS REPORTING:-
Its an unsolicited communication by health
professionals or consumers, pharmaceutical
company to NCC or other organisation
(CDSCO, AMCs) that describes one or more
suspected ADRs in a patient given a medicinal
product that doesn’t drive from study or any
organised data collection scheme. Presently
PvPI is following spontaneous reporting
system to collect data on drug safety.

2. Adverse drug reactions can be monitored
through two ways:-
a)Active surveillance system
b)Passive surveillance system
PASSIVE SURVEILLANCE:- Health professionals are
encouraged to report adverse reactions which
they believe are related to drug directly to-
-Regulatory authority directly
-The company marketing the suspected product

3. • ACTIVE SURVEILLANCE:-
Requires a continuous pre-organised process.
Ex: as in CEM (Coherent event monitoring),
systems for intensified follow up of selected
medicinal products.
PSUR- Periodic safety update report.
PVPI is under control of:-
CDSCO
Directorate general of health services.
Indian Pharmacopoeia Commission (GZB).
National Coordination Centre (NCC).

4. SUSPECTED ADR REPORTING FORM

6. Separate forms are available to record adverse
drug reactions associated with:-
a)transfusion of blood
b)blood and blood related products
c)Adverse event following immunization(AEFI)
ADR form consist of:-
a)Patients information:- Patients initials, age, sex,
weight.
b)Suspected adverse drug reactions:-
Date of reaction started, date of recovery, reaction
description.

7. c)Suspected medication:-
Dechallenge details, rechallenge details,
concomitant drugs, relevany tests, seriousness of
the reaction, outcomes.
In case complete information is not available then
fill all the Essentially Required Items(ERI) for a
quality ICSR. In case ERI not available make sure that
form contain all the mandatory fields.
MANDATORY FIELDS:-
Patient initials
age at onset of reaction
date of onset of reaction

8. Suspected medication
Reporter’s information
ESSENTIALLY REQUIRED ITEMS:-
Patient initials, gender, date of onset of reaction, suspected
medication, dose, date of therapy started, indication of use,
seriousness, outcomes, rechallenge and dechallenge details,
reporter’s information and date of report.
WHO CAN REPORT?
Healthcare professionals and non healthcare professionals
like consumers can report suspected adverse drug reaction.
Pharmaceutical companies can also send ICSRs specific for
their product to NCC.

9. WHY TO REPORT ?
It is a moral responsibility as a healthcare
professional to work in the interest of
public health. The safety of more than
1.2billion is a concern and must be taken
seriously. Use of multi-modal practices,
poor patient compliancesare the other
factors requires ADR reporting.